FDA studies robotic surgery injury reports

The U.S. Food and Drug Administration reportedly has begun investigating voluntary adverse-event reports, including reports of at least five patient deaths in the last year or so, pertaining to the robotic da Vinci Surgical System.

In one lawsuit, a jury in 2012 awarded $7.5 million in damages to the relatives of a Chicago man who died in 2007 following a da Vinci spleen procedure in which, plaintiffs claimed, the victim suffered a fatal intestinal puncture.

A more recent patient death reported to the FDA happened on Sept. 27, 2010, following a da Vinci kidney procedure.

“[T]he patient sustained cuts and lacerations, causing injury to the aorta, left renal artery, splenic vein and proximal renal vein,” according to this report to the FDA. “It is also alleged that during the surgical procedure the patient sustained perforation of the pancreas. The surgeon decided to convert the partial nephrectomy procedure to a radical nephrectomy procedure. A specialist was called in to assist with identification and repair of the damage[d] organs and vessels.”

As a result of “various injuries and in particular the unrepaired and untreated injury to the pancreas, hemorrhagic debris and fluid accumulated in the contiguous residual cavity, causing and/or contributing to the development of a right pleural effusion and pericardial effusion.”

And the patient died the next day.

That report to the FDA included a “manufacturer narrative” that started out, “At this time it is undetermined as to what caused the patient’s death. Several attempts have been made to gather additional information regarding this event from this site without success.”

“Really?”

That was how staff members at Citron Research, an online stock commentary website, responded in its report on the device’s maker. The report, intended primarily for investors, stated that there were dozens of death outcomes within thousands of da Vinci adverse-event reports submitted to the FDA.

“In 2000, the da Vinci Surgical System became the first robotic surgical platform commercially available in the United States to be cleared by the FDA for use in general laparoscopic surgery,” according to Intuitive Surgical Inc., the system’s manufacturer, which adds, “Today, there are 2,585 da Vinci Systems installed in 2,025 hospitals worldwide.”

The system helps surgeons to perform cardiac, thoracic, urologic, gynecologic, pediatric, general, and transoral surgery, according to Intuitive. The surgeon controls the system’s four robotic arms and sees what he or she is doing through a three-dimensional viewer.

Intuitive in March 2013 attributed the spike in reported da Vinci problems to its own FDA medical-device reporting reforms, adding in its statement that “the vast majority of which were related to instruments and not to systems” and did not involve “reportable injuries or deaths.”

To which Citron and many damaged plaintiffs would ask, “What do you mean by ‘reportable’?”

Citron suggested that the shadow of justice may have discouraged reporting to the FDA’s Manufacturer and User Facility Device Experience Database.

“This adverse event dataset is built entirely from voluntary entries,” the Citron report reads. “That means that by definition, the database will never be a complete catalog of the adverse events from da Vinci surgeries. … There is no incentive for the main reporting parties, Intuitive and the hospitals who are its primary customers, to enter cases into MAUDE. We see many cases in which, as soon as the risk of legal liability emerges in a case, the hospital stops providing further information about the patient outcome and post-failure inquiry findings.”

Interpretations of figures aside, here is what we do know. When a patient is seriously injured in a surgical procedure, the victim or, worst case, the victim’s next-of-kin has a right to hold the responsible parties accountable. That maxim applies to medical personnel, and it also applies to makers of surgical systems whose product defect or inadequate training of surgeons results in foreseeable serious injury or death.

There is a justice system in place to adjudicate such matters, and there are attorneys skilled in product liability law who can help victims or their families to ensure that justice is served.

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Victims of a da Vinci surgical system procedure and their loved ones are welcome to receive a free consultation from one of the experienced personal injury attorneys at Reich & Binstock. At no charge, a Reich & Binstock attorney will evaluate one’s circumstances and determine all the legal options. The law firm may be reached toll-free at 1-866-LAW-2400. Its website is www.reichandbinstock.com.